BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD DCM CR TIBIAL BEARING

    MDR report key: 7028960 · Received November 14, 2017

    Report

    Report Number
    0001825034-2017-10117
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    February 17, 2016
    Report Date
    December 12, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - VANGUARD CR FEMUR # 183074 LOT # 832770, BIOMET CC CRUCIATE TRAY # 141237 LOT # J3449270, BIOMET SERIES A THIN PATELLA # 184788 LOT # 219290, COBALT G-HV BONE CEMENT # 402283 LOT # 088320, OPTIVAC KIT DOUBLE MIX # 417200 LOT # 0000989726. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY 9 MONTHS POST INITIAL SURGERY DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808091 VANGUARD DCM CR TIBIAL BEARING PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 890700

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R